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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS

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TERUMO CORPORATION, ASHITAKA CAPIOX FX OXYGENATOR OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Catalog Number CX-FX05RW
Device Problem Increase in Pressure (1491)
Patient Problem Blood Loss (2597)
Event Date 07/12/2018
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Visual inspection upon receipt revealed no defects. The oxygenator module was rinsed by letting physiological saline solution flow through it by gravity. Subsequent visual inspection found the presence of clots formed inside the device. Physiological saline solution was filled and circulated in the oxygenator module and the pressure drop was determined at each flow rate. The obtained values were found to be higher than those of the current product sample. The actual device was fixed with glutaraldehyde solution and the housing component and filter were removed from the oxygenator module. Visual inspection of the filter removed from the oxygenator module found the formation of clots on the outer and inner surfaces. Visual inspection of the oxygenator module, after the housing component and filter having been removed from it, found the formation of clots. The fiber layer was removed from the winding in increments of 2 mm and each layer was subjected to visual inspection. Clots were found to have formed there. There was no anomaly in the state of fiber winding. The outer cylinder was removed and the heat exchanger module was subjected to visual and magnifying inspections. The formation of clots was found on it. Magnifying inspection of the both sides of the filter removed from the oxygenator module in the above revealed the formation of red thrombus on them. There was no anomaly in the diameter of the mesh of the filter. Magnifying inspection of the fiber layers removed from the oxygenator module in the above revealed the formation of clots on them. Electron microscopic inspection of the outer and inner surfaces of the filter removed from the oxygenator module revealed the formation of fibrin nets on them and the adhesion of blood corpuscle components, including red blood cells, deformed red blood cells and blood platelets, to them. Electron microscopic inspection of the upper segments of the fiber layers removed from the oxygenator module above revealed the formation of fibrin nets on them and the adhesion of blood corpuscle components, including red blood cells, deformed red blood cells (echinocytes) and blood platelets, to them. The clots adhering to the surface of the bottom area of the heat exchanger were sampled and inspected under electron microscope. The presence of blood corpuscle components, including deformed red blood cells and the formation of fibrin net were revealed. There is no evidence that this event was related to a device defect or malfunction. During the above investigation, the formation of clots was found on the filters, fibers and heat exchanger housed inside the actual oxygenator module. Electron microscopic inspection of the clots revealed the formation of fibrin nets on it and the adhesion of blood corpuscle components, including red blood cells, deformed red blood cells(echinocytes) and blood platelets, to it. In this case, it is likely that the clots formed due to some factor(s) resulted in the increase in the pressure. From the investigation of the actual device, however, it is difficult to definitively determine the cause of the formation of clots. A review of the device history record of the involved product code/lot number combination revealed no findings. A search of the complaint file found no other report of this nature with the involved product code/lot# combination. The ifu states: "adequate heparinization of the blood is required to prevent it from clotting in the system. Do not reduce heparin during circulation. Otherwise, blood clotting might occur. " (b)(4).
 
Event Description
The user facility reported a pressure increase on the involved capiox device. Around 4 minutes after the initiation of the extracorporeal circulation, the pressure increased. The actual sample was changed out. The amount of blood loss was reported to be unknown. The procedure outcome is unknown. Final patient condition is unknown.
 
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Brand NameCAPIOX FX OXYGENATOR
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer Contact
mark vornheder
reg. no. 2243441
950 elkton blvd
elkton, MD 21921
MDR Report Key7734680
MDR Text Key115537774
Report Number9681834-2018-00142
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K071572
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2021
Device Catalogue NumberCX-FX05RW
Device Lot Number180308
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/08/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/31/2018 Patient Sequence Number: 1
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